IGMPI India



Recall of Potassium Chloride Injection 10 mEq per 100 mL by Baxter

Voluntary recall of one lot of highly concentrated potassium chloride injection 10 mEq per 100 mL has been made by Baxter International due to a complaint of mislabeling of the pouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL instead of 10 mEq per 100 ml.

Potassium Chloride is indicated for treatment of Potassium deficiency and is administered intravenously. Products were recalled as there was a chance of administering lower dose than intended if mislabeled pouch could not be detected at the point of care. This could have been serious as well as life threatening adverse health consequences to patients prone to severe electrolyte imbalance. However till date no adverse events have been reported.

Customers have been notified by Baxter not to use the product from the recalled lot. However unaffected lot numbers can continued to be used according to the instruction leaflet and are available for replacement.

Customers have been notified by Baxter not to use the product from the recalled lot. However unaffected lot numbers can continued to be used according to the instruction leaflet and are available for replacement.